Issue Date: July 30, 2001
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Final
Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA
The “ Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA ” document provides guidance to third party and hospital reprocessors about their responsibility as manufacturers engaged in reprocessing devices labeled for single use under the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and the Food and Drug Modernization Act of 1997. Third Party and hospital reprocessors of single-use devices are subject to all the regulatory requirements currently applicable to original device manufacturers.
Download the Guidance Document
